Category Archives: Drugs for Diabetes

OBJECTIVES: To evaluate glycemic control among children and adults with type 1 diabetes mellitus (T1DM) who consume a very low–carbohydrate diet (VLCD).

METHODS: We conducted an online survey of an international social media group for people with T1DM who follow a VLCD. Respondents included adults and parents of children with T1DM. We assessed current hemoglobin A1c (HbA1c) (primary measure), change in HbA1c after the self-reported beginning of the VLCD, total daily insulin dose, and adverse events. We obtained confirmatory data from diabetes care providers and medical records.

RESULTS: Of 316 respondents, 131 (42%) were parents of children with T1DM, and 57% were of female sex. Suggestive evidence of T1DM (based on a 3-tier scoring system in which researchers took into consideration age and weight at diagnosis, pancreatic autoimmunity, insulin requirement, and clinical presentation) was obtained for 273 (86%) respondents. The mean age at diagnosis was 16 ± 14 years, the duration of diabetes was 11 ± 13 years, and the time following a VLCD was 2.2 ± 3.9 years. Participants had a mean daily carbohydrate intake of 36 ± 15 g. Reported mean HbA1c was 5.67% ± 0.66%. Only 7 (2%) respondents reported diabetes-related hospitalizations in the past year, including 4 (1%) for ketoacidosis and 2 (1%) for hypoglycemia.

CONCLUSIONS: Exceptional glycemic control of T1DM with low rates of adverse events was reported by a community of children and adults who consume a VLCD. The generalizability of these findings requires further studies, including high-quality randomized controlled trials.”

“Global health care giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices, the Justice Department announced today. The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company. GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA). Under the terms of the plea agreement, GSK will pay a total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600. The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court. GSK will also pay $2 billion to resolve its civil liabilities with the federal government under the False Claims Act, as well as the states. The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, as well as additional drugs, and also resolves pricing fraud allegations.”

“The United States alleges that, between 2001 and 2007, GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends. The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia. Since 2007, the FDA has added two black box warnings to the Avandia label to alert physicians about the potential increased risk of (1) congestive heart failure, and (2) myocardial infarction (heart attack). GSK has agreed to plead guilty to failing to report data to the FDA and has agreed to pay a criminal fine in the amount of $242,612,800 for its unlawful conduct concerning Avandia.”

And…

“In its civil settlement agreement, the United States alleges that GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia’s safety profile, causing false claims to be submitted to federal health care programs. Specifically, the United States alleges that GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks. GSK has agreed to pay $657 million relating to false claims arising from misrepresentations about Avandia. The federal share of this settlement is $508 million and the state share is $149 million.”

Does this help you understand why I favor diet modification over drug therapy for type 2 diabetes?

The article notes that liraglutide (Victoza), a GLP-1 analogue, was associated with a 13% relative risk reduction in a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.

Semaglutide, an experimental GLP-1 analogue, also has evidence for cardiovascular death prevention.

Another diabetes drug, Jardiance or empagliflozin, also has evidence for cardiovascular death prevention. Jardiance is an SGLT2 inhibitor.

Read the full MPT article for more details. I find the cost of these drugs to be an interesting yet little discussed detail.

Let’s assume these drugs actually reduce cardiovascular disease risk in T2 diabetics. What if they increase death and disease rates from cancer and infection? You don’t hear much about that, do you?

We still don’t know much about the long-term adverse effects of most of our diabetes drugs. That’s one reason I tend to favor diet modification as a primary diabetes treatment.

“Many primary care professionals manage injection or infusion therapies in patients with diabetes. Few published guidelines have been available to help such professionals and their patients manage these therapies. Herein, we present new, practical, and comprehensive recommendations for diabetes injections and infusions. These recommendations were informed by a large international survey of current practice and were written and vetted by 183 diabetes experts from 54 countries at the Forum for Injection Technique and Therapy: Expert Recommendations (FITTER) workshop held in Rome, Italy, in 2015.”

Average skin thickness is 2 to 2.5 mm, with 90% of people under 3.25 mm.

Use the shortest needles: 6 mm for syringes, 4 mm for pen injectors. The short needles help you avoid injections into muscle. Injection into muscle increases risk of hypoglycemia and wide blood glucose excursions.

Acceptable injection sites: abdomen, thighs, buttocks, upper arms (usually on the back of the arm).

If an arm site is chosen with a 6 mm needle, inject into a lifted skin fold (otherwise you might hit muscle).

When using the 6 mm needle, inject into a lifted skinfold if you are a child or normal-weight adult. Alternatively, insert the needle at a 45 degree angle.

The preferred site for regular insulin (soluble human insulin) is the abdomen, for faster absorption.

Use needles only once. (Admittedly, many get away with multiple uses without much trouble.)

Don’t inject into lipohypertrophy areas. Lipohypertrophy eventually is an issue in half of insulin users. It is a localized area of swelling or lumpiness at the site of prior injections. It’s often easier to feel than to see. Injection into these areas causes erratic absorption of insulin, with potential widely fluctuating and unpredictable blood sugar levels.

Rotate injection sites to avoid lipohypertrophy.

If using cloudy insulins (e.g., NPH and some pre-mixed insulins), gently roll and tip the vial or pen until the solution is milk white.

European authorities and even the U.S. Food and Drug Administration are looking into the possible connection. Stay tuned. Visit The Low Carb Diabetic site (link below) for more details.

“The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has extended the scope of its investigation into the possible link between the sodium glucose cotransporter 2 (SGLT2) inhibitor canagliflozin (Invokana, Vokanamet, Janssen) and amputations to include other drugs of the same class.

Now, the PRAC’s review will include the other SGLT2 inhibitor medicines dapagliflozin (Farxiga, Xigduo XR, AstraZeneca), and empagliflozin (Jardiance, Boehringer Ingelheim), based on the determination that the potential risk may be relevant for them as well.”

PS: SGLT2 inhibitors are the drugs that reduce blood glucose by shunting it into your urine. Makes more sense to me instead to reduce your blood sugar by eating fewer carbohydrates, the primary source of blood sugar in most folks.

Diabetes is a disease of carbohydrate intolerance. Doesn’t that suggest to you that diabetics should reduce or avoid dietary carbohydrates?

The new study at hand was done in Indiana, involving 262 folks with type 2 diabetes. Characteristics of the study subjects:

average age 54

66% women

BMI 41 (very fat)

average Hemoglobin A1c 7.6%

The authors don’t use the term “ketogenic diet,” preferring instead “a diet designed to induce nutritional ketosis” (I’m paraphrasing). For most folks, that’s a diet with under 30 grams of carbohydrate daily, according to the researchers. The study lasted for only 10 weeks.

The drop-out rate was about 10% (25 participants), which is not bad.

Results:

Hemoglobin A1c (a test of diabetes control) dropped to 6.5%, a move in the right direction and equivalent or better than that seen with many diabetes drugs.

Average weight loss was 7.2% of initial body weight.

No severe symptomatic hypoglycemic events.

Number and dose of necessary diabetes drugs were reduced “substantially.”

What’s not to love? Why isn’t this the standard of care?

Click the link below to look for details of the Virta Clinic program used in this study.

I put together a Ketogenic Mediterranean Diet for my patients with diabetes. It reduces dietary carbs to 20-30 grams/day. There’s a free version, but consider the low-cost version that includes recipes and extensive initiation and management advice.

Links

“Do not be deceived: God cannot be mocked. A man reaps what he sows. Whoever sows to please their flesh, from the flesh will reap destruction; whoever sows to please the Spirit, from the Spirit will reap eternal life.”